In Vivo Proof-of-principle Study of Raman Spectroscopy in Trial Participants With Bladder Tumours

Phase 1

• Conditions: Endoscopic Bladder Cancer Diagnosis With Raman
• Interventions: Diagnostic Test: Raman Spectrometry

• Registration Number: NCT05124106
• Lead Sponsor: University Hospital Bispebjerg and Frederiksberg

Brief Summary

The purpose with this clinical investigation is to perform Raman spectroscopy inside the vivid bladder and to acquire Raman spectra of normal and tumour bladder tissue, and in a post-processing step to determine the grade of the tumor.

Detailed Description

The purpose with this clinical investigation is to perform Raman spectroscopy inside the vivid bladder and to acquire Raman spectra of normal and tumour bladder tissue, and in a post-processing step to determine the grade of the bladder tumor.

The recordings and overall results will be compared to standard histo/cytopathological examination of urological tissue to achieve a clinical useful concordance between gold standard histo/cytopathological diagnosis and diagnostic information established by Raman.

The MIB RAMAN SYSTEM in combination with a Raman probe will be used in the operating theatre at Herlev/Copenhagen hospital urology department, where the rigid resectoscopes will be used while the trial participant is under general anesthesia. Each measurement takes about 1-5 seconds and the whole procedure with the fiber optic probes is expected to prolong the operation with 10-15 minutes.

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-05
• Study First Submitted QC: 2021-11-05
• Study First Posted: 2021-11-17
• Study Start: 2021-11-22
• Last Update Submitted: 2021-11-29
• Last Update Posted: 2021-12-13
• Primary Completion: 2022-02-01
• Study Completion: 2022-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

After booking for surgery the trial participants will be informed orally about the study and written material will be given by a doctor or nurse form the study group. If the trial participant accept to enter the study, written informed consent will be obtained. The trial participant will be informed that they can withdraw the informed consent at any time and the treatment will be according to the guidelines of the department.

Exclusion Criteria

• Macroscopic hematuria
• Pregnant or breast-feeding women
• Expected poor compliance
• Persons < 18 years
• Persons who do not read or understand Danish
• Dementia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic ability of Raman spectrometry	Raman Spectrometry	Endoscopic Raman spectrometry during endoscopic bladder cancer surgery

Primary Outcome Measures

Name	Time	Method
Diagnosis of tumor grade by Raman spectometry	4 weeks	To achieve a clinical useful concordance between gold standard histo/cytopathological diagnosis and the information provided through Raman spectroscopy.

Secondary Outcome Measures

Name	Time	Method
To evaluate feasibility of handling the diagnostic optic equipment (MIB RAMAN SYSTEM), the Raman probe and the software, when the urologist examines the bladder for lesions.	4 weeks	Examine results on the sensitivity and specificity for "diagnosis" (normal tissue/tumour) in 30 trial participants using the developed MIB RAMAN SYSTEM.

Trial Locations

Locations (1)

Herlev hospital, Urology department; 🇩🇰 Herlev, Copenhagen, Denmark